Sumatriptan

Overview

Sumatriptan is a serotonin receptor agonist commonly used to treat migraines and sometimes cluster headaches. Sumatriptan is the first of the triptans and was made available in Europe in 1991 to treat migraines. Sumatriptan was granted FDA approval on 28 December 1992.

Indication

A combination sumatriptan and naproxen tablet is indicated for the treatment of migraines with or without auras in patients 12 years of age and older. Sumatriptan nasal powder, nasal spray, subcutaneous injection, and tablets are indicated to treat migraines with or without auras in adults. One of the subcutaneous formulations of sumatriptan is also indicated to treat cluster headaches in adults, while the other subcutaneous formulation is not.

Associated Conditions

Acute Migraine
Acute Cluster headaches

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Nebulized Dexmedetomidine Versus Oral Sumatriptan in Treatment of Post Dural Puncture Headache in Cesarean Section	2024/07/23	NCT06514040	Not Applicable	Completed	Fayoum University Hospital
Migraine Attack Treatment Response Molecular and Clinical BiOmarkers (MAMBO) Phase I	2024/07/16	NCT06503848	N/A	Recruiting	Hospital Universitari Vall d'Hebron Research Institute
Influence of Ubrogepant and Sumatriptan on the Dermal Blood Flow Response to Histamine, Cinnamaldehyde and Capsaicin	2022/12/16	NCT05654298	Not Applicable	Completed	Universitaire Ziekenhuizen KU Leuven
Effect of Sumatriptan on Levcromakalim-Induced Symptoms in Individuals With Migraine	2022/01/27	NCT05211050	Not Applicable	Completed	Danish Headache Center
Mirtazapine vs Sumatriptan in the Treatment of Postdural Puncture Headache	2021/11/05	NCT05108688	Phase 4	Completed	Ain Shams University
Drug-Drug Interaction Study of Evobrutinib and Transporter Substrates	2021/10/01	NCT05064488	Phase 1	Completed	Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Study of Sumatriptan Naproxen Sodium Succinate Tablets for the Treatment of Acute Migraine Attacks	2021/07/01	NCT04948164	Phase 3	UNKNOWN	Peking University Third Hospital
Sumatriptan and Glucose	2020/12/30	NCT04690270	Early Phase 1	UNKNOWN	Cambridge University Hospitals NHS Foundation Trust
A STUDY TO EVALUATE THE EFFECT OF PF-06651600 ON PHARMACOKINETICS OF SINGLE DOSE SUMATRIPTAN IN HEALTHY PARTICIPANTS.	2020/04/21	NCT04355845	Phase 1	Completed	Pfizer
Is Theophylline More Effective Than Sumatriptan in the Treatment of Post-dural Puncture Headache	2020/02/06	NCT04257851	Phase 4	Completed	Damanhour Teaching Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Sumatriptan Succinate	MedVantx, Inc.	66116-413	ORAL	50 mg in 1 1	9/3/2009
Sumatriptan Succinate	Mylan Pharmaceuticals Inc.	0378-5631	ORAL	50 mg in 1 1	7/16/2018
Sumatriptan Succinate	Physicians Total Care, Inc.	54868-5978	ORAL	100 mg in 1 1	5/24/2010
Sumatriptan and Naproxen Sodium	Innovida Phamaceutique Corporation	71800-901	ORAL	85 mg in 1 1	12/9/2020
IMITREX	GlaxoSmithKline LLC	0173-0523	NASAL	20 mg in 1 1	3/22/2024
Sumatriptan	Cipla USA Inc.	69097-644	NASAL	20 mg in 1 1	1/29/2021
Sumatriptan	Direct_Rx	72189-404	ORAL	100 mg in 1 1	3/6/2023
IMITREX	DIRECT RX	61919-408	ORAL	50 mg in 1 1	6/7/2016
Sumatriptan	Baxter Healthcare Corporation	36000-289	SUBCUTANEOUS	6 mg in 0.5 mL	10/6/2021
Sumatriptan	Advanced Rx Pharmacy of Tennessee, LLC	80425-0224	ORAL	100 mg in 1 1	1/12/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
IMIGRAN INJECTION 6 mg/0.5 ml	GLAXO OPERATIONS UK LTD (TRADING AS GLAXO WELLCOME OPERATIONS)	SIN06744P	INJECTION	6 mg/0.5 ml	12/26/1991
SUMATRAN TABLET 50MG	Salutas Pharma GmbH	SIN13667P	TABLET	50mg	6/26/2009
IMIGRAN TABLET 50 mg	Delpharm Poznań S.A.	SIN08419P	TABLET, FILM COATED	50 mg( Equivalent to 70mg as Succinate)	10/26/1995
SUMASON TABLETS 50MG	Unison Pharmaceuticals Pvt. Ltd.	SIN17179P	TABLET, FILM COATED	50mg	2/12/2025

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
SUMATRAN sumatriptan (as succinate) 50 mg tablet blister pack	187216	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/11/2012
SUMATRIPTAN-WGR sumatriptan (as succinate) 50 mg tablet blister pack	267423	Accord Healthcare Pty Ltd	Medicine	A	1/3/2018
SUMATRIPTAN ARROW 100 sumatriptan 100mg (as succinate) tablet blister pack	117727	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	7/10/2007
IPTAM sumatriptan (as succinate) 100mg tablet blister pack	124087	Alphapharm Pty Ltd	Medicine	A	8/15/2006
SUMATRIPTAN-WGR sumatriptan (as succinate) 100 mg tablets blister pack	267424	Accord Healthcare Pty Ltd	Medicine	A	1/3/2018
SUMATRIPTAN INTAS sumatriptan (as succinate) 50 mg tablet blister pack	267421	Accord Healthcare Pty Ltd	Medicine	A	1/3/2018
IMIGRAN MIGRAINE LACTOSE FREE sumatriptan 50 mg (as succinate) tablet blister pack	410293	Aspen Pharmacare Australia Pty Ltd	Medicine	A	6/9/2023
Sumatriptan 100 mg tablet bulk	346507	Alphapharm Pty Ltd	Medicine	A	10/23/2020
Sumatriptan Tablets 50 mg (OTC) blister pack	159389	Alphapharm Pty Ltd	Medicine	A	2/16/2009
CHEMMART SUMATRIPTAN sumatriptan 100 mg (as succinate) tablet blister pack	160198	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/18/2010

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
IMIGRAN 10 mg SOLUCION PARA PULVERIZACION NASAL.	Glaxosmithkline S.A.	61629	SOLUCION PARA PULVERIZACION NASAL	Medicamento Sujeto A Prescripción Médica	Commercialized
SUMATRIPTAN KLARIA 27 MG PELICULA BUCAL	Klaria Ab	90084	Película bucal (buccal film)	Medicamento Sujeto A Prescripción Médica	Not Commercialized
IMIGRAN 20 mg SOLUCION PARA PULVERIZACION NASAL.	Glaxosmithkline S.A.	61630	SOLUCION PARA PULVERIZACION NASAL	Medicamento Sujeto A Prescripción Médica	Commercialized
IMIGRAN 20 MG SOLUCION PARA PULVERIZACION NASAL.	Glaxosmithkline (Ireland) Limited	3314999C	SOLUCION PARA PULVERIZACION NASAL	Medicamento Sujeto A Prescripción Médica	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

Large Norwegian Study Finds No Increased Risk of Autism or ADHD in Children Exposed to Triptans During Pregnancy

3 months ago

A comprehensive Norwegian population study of 26,210 pregnancies found no increased risk of neurodevelopmental disorders, including autism and ADHD, in children whose mothers used triptans for migraine treatment during pregnancy.

Migraine Treatment Advances: CGRP Inhibitors, Digital Therapeutics, and Novel Compounds Highlight 2024

8 months ago

• The American Headache Society now recommends CGRP-targeting therapies as a first-line approach for migraine prevention, marking a significant shift in treatment strategy. • Nerivio, a remote electrical neuromodulation device, received FDA approval for expanded use in pediatric patients aged 8 and older for acute migraine treatment. • Clinical trials show promise for digital therapeutic CT-132 in reducing monthly migraine days, offering a novel non-pharmacological option for episodic migraine prevention.

Triptans Outperform Newer Migraine Drugs in Efficacy, Meta-Analysis Shows

a year ago

• A comprehensive meta-analysis reveals that older triptan medications, like eletriptan, are more effective for acute migraine treatment than newer gepants. • The study suggests eletriptan, rizatriptan, sumatriptan, and zolmitriptan offer superior pain relief and sustained pain freedom compared to lasmiditan, rimegepant and ubrogepant. • Researchers recommend triptans as a first-line treatment for migraines, given their efficacy and lower cost, but note contraindications for patients with cardiovascular issues. • The analysis highlights the underutilization of triptans in migraine management, urging healthcare professionals to consider them as a preferred option.

Help Us Improve

Your feedback helps us provide better drug information and insights.

AI-Powered Research

Premium Access